Anusha Thallam
Guntûr
Summary
Senior Clinical Data Coordinator with extensive expertise in clinical data management and project oversight at ICON Clinical Research. Demonstrated success in leading teams to improve data quality and streamline processes, resulting in enhanced project outcomes and in start up , conduct and close out phases. Recognized for strong communication skills and adaptability, contributing to operational excellence and efficient project execution. Future aspirations include leveraging skills to drive innovation within clinical research methodologies.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior clinical Data coordinator
ICON Clinical Res and search
09.2023 - Current
- Creating CRF Completion Guidelines (CCG), SAE reconciliation Guidelines,etc
- Data validation and cleaning Conducting SAE & third-party data reconciliations performing early and final database QC activities Database lock activities
- Maintaining Clinical Study Documents and archiving as appropriate Responsible for completeness, timely delivery and quality of clinical data
- Lead and coordinate other team members within the department on assigned studies Mentor project team members
- Represent Data Management (DM) function in external client meetings and presentations
- Involved in Postproduction changes of the database
- Generation of various reports as per study requirement
- Trained new resources to perform data validation until they can work independently
- Identified and raised clinical data discrepancies on time
- Handling multiple external vendors and performing the review on monthly basis
- Keeps Global Data Manager (GDM) and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts)
- Maintaining the DHE’s Documented
- Perform Quality control of the data
- Responsible for all the clinical data management activities from start to end
- Support and act as backup of the study data manager
- Perform all freezing and locking activities
- Perform on eTMF filing on the study
- Involved in reviewing the FTS documents for vendor related activities
- Involved resolving data discrepancies identified by system or through manual checks
Senior Clinical Data Coordinator
QuintilesIMS (IQVIA)
04.2014 - 08.2023
- Utilize current study documentation, including protocol, Case Report Forms (CRFs), cleaning guidelines, etc., to review the data.
- Conduct an in-house data review for various data types, such as IVRS and other external vendor reconciliations.
- Generate and close queries, or apply self-evident corrections to the data according to the relevant guidelines, ensuring effective query management.
- Performing UAT for database and edit checks, identifying and reporting protocol deviations, conducting reconciliation of SAEs, sending out queries as required, and notifying relevant Safety Groups of possible issues for their action. Lock site(s) within the EDC system and remove users' data modification privileges.
- Interact with site (via mail) as required
- Perform early and final database QC activities.
- Update all relevant tracking systems on an ongoing basis.
- Keep the manager and the Data Operational Coordinator informed about work progress and any issues, to avoid surprises.
- Requires regular interaction, supervision by a manager, or an assigned mentor.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP. Participate in the completion of all activities necessary for the finalization and transfer of the clinical database and related project documents to the sponsor.
- Performing the close-out activities (locking the e-CRF, preparing the clean patient tracker), generation of reports on a regular basis, and drafting the DB lock plan and DB lock checklist.
- Performs back-end check reviews.
- Understand and comply with all applicable standard operating procedures and working instructions.
Education
B.TECH - BIOINFORMATICS
SRM UNIVERSITY
CHENNAI06-2010
Skills
- Clinical Data Management (Start-up, conduct, and close-out)
- Fast learner
- Communication skills
- Microsoft Office
- Data archiving
- Project Management
Certification
- Diploma In clinical Research -IDDCR Hyderabad.
Languages
6,C2,6,C2
Disclaimer
- I hereby declare that information given is true to the best of my knowledge.
Anusha Thallam
28-FEB-2025
Software Knowledge
- Imedidata Rave
- Inform
- OC_RDC
- PRISM
- VEEVA VAULT
- ARMADA (SPECTR)
Therapeutics Area of experience
Currently working on Multiple sclerosis, Parkinson’s and Asthma Therapeutic areas.
Timeline
Senior clinical Data coordinator
ICON Clinical Res and search
09.2023 - Current
Senior Clinical Data Coordinator
QuintilesIMS (IQVIA)
04.2014 - 08.2023
B.TECH - BIOINFORMATICS
SRM UNIVERSITY
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